Adherence, Improvement Measure (AIM) System (AIM)

This study has been completed.

Sponsor:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT01252212

First Posted: December 2, 2010

Last Update Posted: November 20, 2013

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In this project, we will work directly with underserved patients in a safety-net setting to conduct a randomized clinical trial of standard-of-care adherence counseling versus a novel adherence intervention embedded in an existing PHR that uses cellular phone short message service (SMS) reminders and patient responses to the reminders. We will compare adherence rates in both arms as assessed by antiretroviral medication concentrations in hair samples and self-report; clinical outcomes will also be compared in the two arms. The project will examine medication adherence for antiretroviral medications and treatments of common conditions such as depression, hypertension, diabetes and hypercholesterolemia.

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

HIV viral load [ Time Frame: 12 month ]

The primary analyses of the 12-month trial data will compare the two study groups with respect to (i) change from baseline in CD4 T-cell count; and (ii) proportion of patients whose HIV viral load (VL) level is detectable. We will use repeated-measures analysis techniques to estimate longitudinal prevalence at the population level (via generalized estimating equations) and at the individual levels (via generalized linear mixed models)[25].

Secondary Outcome Measures:

Level of antiretroviral medication in hair [ Time Frame: 12 month ]

We will evaluate the antiretroviral level in hair samples from patients to determine compliance with medications.

The patients randomized to this arm will have a SMS message sent to them regarding medication adherence for antiretroviral medications, anti-hypertensive medications, anti-depressants, hyperglycemic controlling medications and hypercholesterolemia controlling medications as well as life style supportive suggestions.

Behavioral: SMS medication adherence

SMS messages to cell phones.

Other Name: mobile health messages for health conditions and medications

Active Comparator: No SMS messages

The patients randomized to this arm will have a SMS message sent to them regarding healthy life style supportive suggestions.

Behavioral: No SMS adherence reminder

In this arm, patients will be sent supportive lifestyle suggestions to their phone using SMS technology but will not be sent a reminder regarding their medication adherence.

Other Name: No medication adherence or disease specific messages.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Older than 18

Evidence of HIV-1 infection, based on patient's medical history or results of laboratory tests

Detectable Viral Load, based on patient's medical record

Receiving primary medical care at the AIDS Program at SFGH

Able and willing to give informed consent to be randomized to study arms

Willing to use the patient portal

Has a cell phone with ability to receive and send unlimited SMS texts, Patient of the HIV/AIDS Clinic at ward 86, SFGH

Exclusion Criteria:

Failure to meet inclusion criteria

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252212